Retrospective Database Study: Survival of Direct Composite Restorations Placed Under General Anesthesia in Adult Patients With Intellectual and/or Physical Disabilities and Risk Factors for Repeated Dental Treatment in General Anesthesia

NCT04407520 | Completed

• 2 other identifiers: Survival-Disabled15/1/18
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to assess the survival of direct anterior and/or posterior composite restoration placed in general anesthesia in permanent teeth of adult patients with intellectual and/or physical disabilities. Further aim is to identify potential risk factors predicting repeated dental treatment under general anesthesia. Survival of composite restorations placed under general anesthesia in adult patients with intellectual and/or physical disabilities between 2011 and 2019 will be retrospectively analysed. Failure is defined as the need for replacement of at least one surface of the original restoration or extraction of the tooth. Individual-, tooth- and restoration-related factors are obtained from digital and paper-based dental records. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). The effect of potential risk factors on failure will be tested using univariate log-rank tests and multivariate Cox-regression analysis. Adult patients with intellectual and/or physical disabilities who received dental treatment under general anesthesia between 2011 and 2017 will be retrospectively analyzed. Demographic, anamnestic, oral health and treatment factors will be obtained from digital and paper-based dental records. Duration of intervals without a subsequent dental treatment under general anesthesia will be assessed using Kaplan-Meier statistics. Potential predictive factors will be tested using log-rank tests and multi-variate Cox-regression analysis.

Conditions

Intellectual and/or Physical Disabilities; Dental Treatment Under General Anesthesia

Outcome Measures

Primary Outcomes (1)

• Failure of restoration placed under general anesthesia

  Failure is defined as the need for replacement of at least one surface of the original restoration or extraction of the tooth.

  2011-2019

Secondary Outcomes (1)

• Repeated dental treatment under general anesthesia

  2011-2017

Study Arms (1)

Adult patients with intellectual and/or physical disabilities

Adult patients with intellectual and/or physical disabilities requiring dental treatment under general anesthesia

Other: No patient treatment is associated with the study

Interventions

No patient treatment is associated with the study OTHER

No patient treatment is associated with the study.

Adult patients with intellectual and/or physical disabilities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with intellectual and/or physical disabilities and need for dental treatment under general anesthesia.

You may qualify if:

• Adult patients with intellectual and/or physical disabilities that were treated under general anesthesia in the Department of Preventive Dentistry, Periodontology and Cariology between January 2011 and December 2019

You may not qualify if:

• none

Sponsors & Collaborators

• University of Göttingen: lead

Related Publications (2)

• Maes MS, Kanzow P, Hrasky V, Wiegand A. Survival of direct composite restorations placed under general anesthesia in adult patients with intellectual and/or physical disabilities. Clin Oral Investig. 2021 Jul;25(7):4563-4569. doi: 10.1007/s00784-020-03770-y. Epub 2021 Jan 15.

  PMID: 33449193 RESULT

• Maes MS, Kanzow P, Biermann J, Leha A, Hrasky V, Wiegand A. Risk factors for repeated general anesthesia for dental treatment of adult patients with intellectual and/or physical disabilities. Clin Oral Investig. 2022 Feb;26(2):1695-1700. doi: 10.1007/s00784-021-04142-w. Epub 2021 Aug 25.

  PMID: 34432139 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Dental Practitioner

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 29, 2020
• Study Start: January 21, 2011
• Primary Completion: December 31, 2019
• Study Completion: May 1, 2020
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share